Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
Oral Cavity SCC
Bottom Line
View on ClinicalTrials.gov: NCT03021993 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate Using Pathological Response |
4 | — |
| SECONDARY Level of Treg Cells in Peripheral Blood Using Immunostaining |
7.7; 9.2 | — |
| SECONDARY Level of Activated T-cells in Peripheral Blood |
58; 62.2 | — |
| SECONDARY Level of Immune Stimulatory Cytokines in Peripheral Blood |
26.4; 36.7 | — |
| SECONDARY Expression of IFN-gamma in CD4+ Cells |
20; 23.9 | — |
| SECONDARY Expression of Granzyme-B in CD8+ Cells From Peripheral Blood |
46.7; 55.5 | — |
| SECONDARY Expression of CD8+ Cells Expressing Granzyme B (Cytolytic Response) From Peripheral Blood |
34.7; 42.6 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed histologically proven locoregional OCSCC without evidence of distant metastases and a clinically determined T-stage of 2-4,
OR
Recurrent or persistent histologically proven locoregional OCSCC that was initially treated with surgery alone, and a clinically determined recurrent T-stage of 2-4.
Note - OCSCC includes the subsites of oral tongue, floor of mouth, gingiva, retromolar trigone, and buccal mucosa.
Note - To allow sufficient tumor tissue for the immunological analyses, patients with T-stage 1 OCSCC will be excluded
- Greater than or equal to 18 years of age
- ECOG performance status of 0 or 1
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
- WBC > 2,000/µL
- Absolute Neutrophil Count >1,500/µL
- Platelets > 100 X 103/µL
- Hemoglobin > 9.0 g/dL
- Serum creatinine 40mL/min (if using the Cockcroft-Gault formula below):
Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
- AST/ALT ≤ 3 x ULN
- Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Data sourced from ClinicalTrials.gov (NCT03021993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.